The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants

NCT ID: NCT03748472

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2022-03-01

Brief Summary

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SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.

Detailed Description

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Conditions

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Premature Infant Respiratory Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bolus feeding

Group Type EXPERIMENTAL

Bolus feeding

Intervention Type PROCEDURE

Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.

continuous gavage feeding

Group Type EXPERIMENTAL

Continuous gavage feeding

Intervention Type PROCEDURE

Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.

Interventions

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Continuous gavage feeding

Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.

Intervention Type PROCEDURE

Bolus feeding

Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Premature Infants (GA\<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding\>100 ml/kg/day

Exclusion Criteria

Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.

Instability because of:

Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Liron Borenstein MD

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Feeding length and oxygenation

Identifier Type: -

Identifier Source: org_study_id

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